Skip to main content
Clinical Trials/NCT04783818
NCT04783818
Completed
Not Applicable

Multicenter Retrospective Evaluation Study of the Adjuvant Radiotherapy's Effect on One and Two Stages Prosthetic Breast Reconstruction and on Autologous Reconstruction

Humanitas Clinical and Research Center1 site in 1 country3,200 target enrollmentJune 6, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mammaplasty
Sponsor
Humanitas Clinical and Research Center
Enrollment
3200
Locations
1
Primary Endpoint
Reconstruction failure
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

For patients with breast cancer subject to a mastectomy, preserving the morphology of the breast with immediate reconstruction is a crucial aspect to preserve the quality of life.

There are several types of breast reconstruction: prosthetic in one or two stages and autologous reconstruction.

Adjuvant radiotherapy has shown an improvement of the overall survival and of the local control for patients with positive lymph nodes.

Despite the undoubted cancer benefits, several studies have shown the negative impact of radiotherapy on breast reconstruction.

However, there are few studies with a significant number that evaluate the effect of radiotherapy on the three types of reconstruction.

In particular, given the extreme variability in clinical approaches, there is no certainty about the best reconstructive timing compared to radiotherapy, the iterations with dermic matrices as well as the usefulness of ancillary procedures such as autologous adipose grafting.

The aim of this study is to compare retrospectively these three types of reconstruction techniques to evaluate the effect of radiotherapy on different reconstructive modes.

Registry
clinicaltrials.gov
Start Date
June 6, 2020
End Date
January 25, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Humanitas Clinical and Research Center
Responsible Party
Principal Investigator
Principal Investigator

Andrea Lisa

Principal Investigator

Humanitas Clinical and Research Center

Eligibility Criteria

Inclusion Criteria

  • Patients subjected to mastectomy and immediate reconstruction directly with prostheses, in two times and by autologue flaps (TRAM, Latissimus Dorsi Flap, DIEP and any other method)

Exclusion Criteria

  • Delayed prosthetic reconstruction

Outcomes

Primary Outcomes

Reconstruction failure

Time Frame: 2 years

Complication rate (as hematoma, seroma, prosthetic exposure, skin and fat necrosis) that resulted in explant (prosthetic, expander or flap)

Secondary Outcomes

  • Reconstruction Complications(2 years)

Study Sites (1)

Loading locations...

Similar Trials